Safety and Efficacy of Saxagliptin for Glycemic Control in Non-Critically Ill Hospitalized Patient

The current professional organization guidelines recommend insulin as the preferred
treatment for hospitalized patients. It is recommended that most critically ill patients
should receive insulin infusion therapy and non-critically ill patients should receive basal
bolus insulin therapy in the hospital.

The study will test the hypothesis that treatment with saxagliptin is non-inferior to
treatment with basal bolus insulin in this group of patients during their hospital stay. The
study will evaluate the effect of saxagliptin, a DPP4 inhibitor, on glycemic control in
non-critically ill hospitalized patients with type 2 diabetes mellitus (T2DM)

The primary outcome will be mean daily blood glucose levels during hospital days 2 to 5. The
study is designed to detect a non-inferiority margin of 20% in the saxagliptin group as
compared to the control group

Inclusion Criteria:

- Patients with T2DM and HbA1C ≤7.5% on ≤1 non-insulin hypoglycemic agent or HbA1C
≤7.0% on ≤2 non-insulin hypoglycemic agents admitted to the hospital for a
non-critical illness.

- Written informed consent.

Exclusion Criteria:

- Admitted to or expected to require admission to ICU

- Patients with a history of diabetic ketoacidosis or hyperosmolar state

- HbA1c >7.5% at the time of admission or within 3 months before admission

- Insulin requiring before admission

- Unable to take oral food or medications

- Systemic steroid use

- Pregnancy or breastfeeding

- Women of Child-Bearing Potential (WOCBP) who are unwilling or unable to use an
acceptable method to avoid pregnancy for the entire study period and up to 4 weeks
after the last dose of study drug.

- History of pancreatitis or active gallbladder disease

- End stage renal disease on dialysis

- Hypersensitivity to saxagliptin or another contraindication to DPP4 inhibitors

- Subject unable to give informed consent